Facts

The basics
Facts every couple should know
Increasing fertility awareness
Today’s treatment options

The basics

Infertility is defined as 12 months of unsuccessful conception for women under 35. For women over 35, this decreases to six months of unsuccessful conception.
Infertility affects approximately 2.1 million couples in the United States (that represents about 10% to 20% of the reproductive-age population).¹
Infertility is not associated with any specific race or ethnicity.

Facts every couple should know

Infertility affects men and women almost equally. Infertility is identified as a male issue in about one-third of cases, and a female concern in another one-third of cases.²
The remaining one-third of infertility cases are caused by a mix of male and female factors, or by unknown factors.²
A woman is most fertile in her mid-20s. Her fertility declines until she reaches 30, and then drops rapidly. The most common female infertility factor is an ovulation disorder.

Men also experience a decrease in fertility as they age. The most common reasons for male infertility include azoospermia (no sperm cells are produced) and oligospermia (few sperm cells are produced).

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Increasing fertility awareness

Infertility continues to be a recognized medical condition.
1.2 million women, or 2% of women of childbearing age had an infertility appointment within the previous year.³

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Today’s treatment options

Most infertility cases are treated with conventional medical therapies such as medication or surgery, although other techniques, such as ovarian stimulation followed by IVF, can increase the chances of success.
Since 1981, when IVF was first introduced in the US, more than 100,000 American babies have been born through this procedure. According to the Centers for Disease Control and Prevention, in 2006 138,198 ART cycles were performed, resulting in 41,343 live births (deliveries of one or more living infants), and 54,656 babies.³ This last figure is better than the chances a perfectly fertile couple has each month of achieving pregnancy and carrying a fetus to term.
In vitro fertilization (IVF) accounts for approximately 99% of assisted reproductive technology services, with about 138,198 IVF cases reported in 2006.³
Another available option for couples is called intracytoplasmic sperm injection (ICSI). This reproductive technique involves capturing a single sperm and injecting it directly into the egg, a procedure that was first described in 1992. In 1995, the Society for Reproductive Medicine declared that ICSI was an accepted treatment for infertility.

Reference
1. National Center for Health Statistics.
2. The National Women’s Health Information Center. U.S. Department of Health and Human Services, Office on Women’s Health.
3. U.S. Department of Health and Human Services. Centers for Disease Control and Prevention. Assisted Reproductive Technology Success Rates. National Summary and Fertility Clinic Reports, November 2006.

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Follistim^® AQ (follitropin beta injection) is approved to help women who have problems with ovulation. Follistim® AQ will not help women whose ovaries do not work at all (primary ovarian failure). Follistim^® AQ is also for women that are in an assisted reproductive technology (ART) program, such as in vitro fertilization.

Important Safety Information:

Always follow your health care professional’s dosing instructions when administering Follistim^® AQ Cartridge. Your health care professional has individualized the dose to be administered based on your medical history. Do not change your dose unless instructed by your health care professional.

Do not use Follistim^® AQ if you are allergic to recombinant human FSH products; have primary ovarian failure (your ovaries do not work at all); are pregnant or think you might be pregnant; have uncontrolled thyroid or adrenal gland problems; have tumors in your ovaries, breasts, uterus, hypothalamus, or pituitary gland; have heavy or irregular vaginal bleeding and the cause is not known; have ovarian cysts or enlarged ovaries not due to polycystic ovary syndrome (PCOS); or are allergic to streptomycin or neomycin. Follistim^® AQ may contain traces of these antibiotics and may cause allergic reactions.

Follistim^® AQ may cause ovarian hyperstimulation syndrome (OHSS), which is a serious medical problem that can happen when the ovaries are overstimulated. In rare cases it has caused death. OHSS causes fluid to build up suddenly in the stomach and chest areas. OHSS may occur after treatment with Follistim^® AQ. Call your health care professional right away if you get any of the following symptoms: severe pelvic pain (lower stomach area), nausea, vomiting, sudden weight gain, or reduced urine output.

Follistim^® AQ and other FSH products may cause serious lung problems including fluid in the lungs, trouble breathing, and worsening of asthma. Follistim^® AQ and other FSH products may also cause blood clots in blood vessels. This can lead to blood vessel problems (thrombophlebitis), stroke, loss of limb, or a blood clot in the lung (pulmonary embolus).

Follistim^® AQ and other FSH products can cause multiple births. Your health care professional will discuss your chances of multiple births.

Follistim^® AQ should only be prescribed by physicians experienced in infertility treatments.

Other side effects with Follistim^® AQ include stomach pain, gas, pelvic pain, nausea, breast pain, injection site problems, enlarged stomach area, back pain, constipation, headache, and ovarian pain. If you get any side effects that concern you, call your health care professional. These are not all the side effects of Follistim^® AQ. Contact your doctor or other health care professional without delay if you are experiencing symptoms including significant abdominal pain or if symptoms develop some days after the last injection has been given.

Please click here for important Product Information on Follistim^® AQ Cartridge.

Please click here for important Product Information on Follistim^® AQ Vial.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.

Pregnyl^® (chorionic gonadotropin for injection, USP) is approved to induce ovulation and pregnancy in women who have problems with ovulation and who have been appropriately pretreated with human menopausal gonadotropins (medications containing follicle-stimulating hormone [FSH] and luteinizing hormone [LH]). Pregnyl^® will not help women whose ovaries do not work at all (primary ovarian failure).

Important Safety Information:
Do not use Pregnyl^® if you are allergic to human chorionic gonadotropin.

Pregnyl^® should be used in conjunction with human menopausal gonadotropins. Pregnyl^® should only be prescribed by physicians experienced in infertility treatments.

Pregnyl^® may cause ovarian hyperstimulation syndrome (OHSS), which is a serious medical problem that can happen when the ovaries are overstimulated. In rare cases it has caused death. OHSS causes fluid to build up suddenly in the stomach and chest areas. OHSS may occur after treatment with Pregnyl^®. Call your health care professional right away if you get any of the following symptoms: severe pelvic pain (lower stomach area), nausea, vomiting, sudden weight gain, or reduced urine output.

Pregnyl^® may also cause rupture of ovarian cysts resulting in internal bleeding (hemoperitoneum), multiple births, and artery blockage by a blood clot (arterial thromboembolism).

Other side effects with Pregnyl^® include headache, irritability, restlessness, depression, fatigue, edema, and pain at the site of injection. If you get any side effects that concern you, call your health care professional.

Please click here for important Product Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.

Ganirelix Acetate Injection is approved for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation.

Important Safety Information:
Do not use Ganirelix Acetate Injection if you are allergic to ganirelix acetate or any of its components, gonadotropin releasing hormone (GnRH) or any other GnRH analog (including GnRH agonists and antagonists), or if you are pregnant or think you might be pregnant.

Ganirelix Acetate Injection should only be prescribed by physicians experienced in infertility treatments. Before starting treatment with Ganirelix, pregnancy must be excluded.

Hypersensitivity (allergic) reactions, some severe, have been reported after the first dose of Ganirelix Acetate Injection. Call your health care professional right away if you get any of the following symptoms: hives, difficulty breathing, chest tightness, high or low blood pressure, vomiting, or diarrhea. The packaging of this product contains natural rubber latex which may cause allergic reactions.

Ganirelix Acetate Injection may cause ovarian hyperstimulation syndrome (OHSS), which is a serious medical problem that can happen when the ovaries are overstimulated. In rare cases it has caused death. OHSS causes fluid to build up suddenly in the stomach and chest areas. Call your health care professional right away if you get any of the following symptoms: severe pelvic pain (lower stomach area), nausea, vomiting, sudden weight gain, or reduced urine output.

Other side effects with Ganirelix Acetate Injection include abdominal pain, death of unborn child, headache, vaginal bleeding, injection site reaction, and nausea. If you get any side effects that concern you, call your health care professional.

Please click here for important Product Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.